MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for BD? ORAL DISPENSING SYRINGE 10 ML 305219 manufactured by Becton Dickinson Medical Systems.
[145790930]
Medical device expiration date: unknown. Initial reporter phone #: unknown. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: no root cause can be determined as no samples were received. Rationale: capa is not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[145790931]
It was reported that scale markings are rubbing off with a bd? Oral dispensing syringe 10 ml. The following information was provided by the initial reporter: material no. : 305219, batch no. : unknown. It was reported that the markings are rubbing off after a few days of use and washing the syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2019-00513 |
| MDR Report Key | 8587917 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Street | ROUTE 7 AND GRACE WAY |
| Manufacturer City | CANAAN CT 06018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD? ORAL DISPENSING SYRINGE 10 ML |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYW |
| Date Received | 2019-05-07 |
| Catalog Number | 305219 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Address | ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |